This lateral flow immunoassay is intended for qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen in direct anterior nasal swab specimens from individuals who are suspected of having COVID-19 by their health-care provider within 5 days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over 2 or 3 days with at least 24 hours and no more than 48 hours between tests. Emergency use of this test is limited to authorized laboratories.